A Study of Advanced or Metastatic Non-small Cell Lung Cancer
A Phase 2 Study to Evaluate LY2603618 in Combination With Pemetrexed in Patients With Advanced or Metastatic Non-small Cell Lung Cancer
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Faktiske)
Tilmelding
Fase
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Arizona
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Tucson, Arizona, Forenede Stater, 85704
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Colorado
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Denver, Colorado, Forenede Stater, 80218
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Florida
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Tampa, Florida, Forenede Stater, 33612
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Ohio
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Kettering, Ohio, Forenede Stater, 45409
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Oregon
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Portland, Oregon, Forenede Stater, 97213
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Texas
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Dallas, Texas, Forenede Stater, 75201
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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The Woodlands, Texas, Forenede Stater, 77380
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tyler, Texas, Forenede Stater, 75702
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Washington
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Yakima, Washington, Forenede Stater, 98902
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Orbassano, Italien, 10043
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Seoul, Korea, Republikken, 138-736
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Taichung, Taiwan, 407
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Tainan, Taiwan, 70403
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Must agree to have a tumor biopsy at screening
- Must have a diagnosis of advanced or metastatic non-squamous non-small cell lung cancer that has progressed after certain prior treatment
- Must be available for the duration of the study and willing to follow the study procedures
- If participant is a woman that is capable of having children, must have a negative pregnancy test within 7 days of taking first dose of study drug
- Must have discontinued radiation therapy at least 4 weeks before entering this study
Exclusion Criteria:
- Must not have taken an unapproved drug as treatment for any indication within the last 28 days before starting study treatment.
- Must not be pregnant or lactating, are considering becoming pregnant, or are considering fathering a child. Males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial until the participant's physician considers it safe to become pregnant or father a child.
- Must not have known positive test in human immunodeficiency virus (HIV), hepatitis B surface antigen (HBSAg), or hepatitis C antibodies (HCAb).
- Must not have previously participated in a study involving LY2603618
- Must not have previously taken pemetrexed for cancer
- Must not have a known allergy to LY2603618 or pemetrexed
- Must not currently have an infection that may affect participant's ability to tolerate the therapy
- Must not have a serious medical condition or disorder that would make it unsafe for you to participate in the study such as uncontrolled diabetes or chest pain due to heart disease
- If taking certain medications called non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen, must be able to stop taking these medications according to certain guidelines
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Antal våben
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
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Eksperimentel: LY2603618 and Pemetrexed
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150 milligram per square meter (mg/m^2) intravenously on Day 2 of each 21 day cycle repeating every 21 days for a minimum of 2 cycles continuing until disease progression
500 mg/m^2 intravenously on Day 1 of each 21 Day cycle repeating every 21 days for a minimum of 2 cycles or until disease progression
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Overall Tumor Response - Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Overall Response Rate (ORR)]
Tidsramme: Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months)
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Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1).
CR is a disappearance of all target and non-target lesions and normalization of tumor marker level.
PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions.
Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
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Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months)
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of Participants Who Achieved a Best Response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) (Clinical Benefit Rate)
Tidsramme: Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months)
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Clinical benefit rate is the best response CR, PR, or stable disease (SD) as classified by the investigators according to the RECIST v1.1.
CR is a disappearance of all target and non-target lesions and normalization of tumor marker level.
PR is an at least 30% decrease in the sum of the diameters of target lesions (taking as reference the baseline sum diameter) without progression of not-target lesions or appearance of new lesions.
SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum diameter since treatment started.
Clinical benefit rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with at least 1 measurable lesion, multiplied by 100.
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Baseline until Progressive Disease or Study Discontinuation (Up to 23 Months)
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Progression-free Survival (PFS)
Tidsramme: Baseline to Progressive Disease or Death Due to Any Cause (Up to 27.1 Months)
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Progression-free survival (PFS) time was defined as the time from the date of randomization to the first date of progressive disease (symptomatic or objective) or death due to any cause, whichever occurred first.
For participants who were not known to have died or progressed as of the data-inclusion cutoff date, PFS time was censored at the date of the last objective progression-free disease assessment prior to the date of any subsequent systematic anticancer therapy.
PFS was summarized using Kaplan-Meier estimates.
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Baseline to Progressive Disease or Death Due to Any Cause (Up to 27.1 Months)
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Duration of Response
Tidsramme: First Observation of CR or PR until Progressive Disease or Death Due to Any Cause (Up to 23 Months)
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Duration of Response is defined as the time from the first observation of CR or PR to the first observation of progressive disease (PD) or death from any cause.
A response is defined as a confirmed objective status of CR or PR.
For participants who are not known to have died as of the data inclusion cut-off date and who do not have PD, the duration will be censored at the date of the last objective progression free disease assessment prior to the date of any subsequent anticancer therapy.
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First Observation of CR or PR until Progressive Disease or Death Due to Any Cause (Up to 23 Months)
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Change in Symptom Burden Scores of Lung Cancer Symptom Scale (LCSS)
Tidsramme: Baseline until End of Study (Up to 27.1 Months)
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The LCSS participants scale is a 9-item questionnaire.
Six questions are symptom-specific measures for lung cancer (appetite, fatigue, cough, dyspnea, hemoptysis and pain), and 3 summation items describe total symptomatic distress, activity status, and overall quality of life.
Participant responses were measured using visual analogue scales (VAS) with 100-milliliter (mm) lines.
Scores range from 0 (for best outcome) to 100 (for worst outcome).
The Average Symptom Burden Index (ASBI) was calculated as the mean of 6 symptom-specific questions from the LCSS.
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Baseline until End of Study (Up to 27.1 Months)
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Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY2603618
Tidsramme: Day 2 and Day 3 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hr; EOI + 4-6 hr; EOI + 20-28 hr; anytime on Day 8 of Cycle 1 and Cycle 2
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Day 2 and Day 3 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hr; EOI + 4-6 hr; EOI + 20-28 hr; anytime on Day 8 of Cycle 1 and Cycle 2
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PK: Maximum Plasma Concentration (Cmax) of Pemetrexed
Tidsramme: Day 1 and Day 2 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hour (hr); EOI + 4-6- hr; EOI + 20-28 hr
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Day 1 and Day 2 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hour (hr); EOI + 4-6- hr; EOI + 20-28 hr
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PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of LY2603618
Tidsramme: Day 2 and Day 3 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hr; EOI + 4-6 hr; EOI + 20-28 hr; anytime on Day 8 of Cycle 1 and Cycle 2
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Day 2 and Day 3 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hr; EOI + 4-6 hr; EOI + 20-28 hr; anytime on Day 8 of Cycle 1 and Cycle 2
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PK: Area Under the Plasma Concentration vs. Time Curve From Time Zero to Infinity [AUC(0-∞)] of Pemetrexed
Tidsramme: Day 1 and Day 2 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hour (hr); EOI + 4-6- hr; EOI + 20-28 hr
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Day 1 and Day 2 of Cycle 1 and Cycle 2: Prior to End of Infusion (EOI); EOI + 1-2 hour (hr); EOI + 4-6- hr; EOI + 20-28 hr
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studiestart
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
Studieafslutning (Faktiske)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Neoplasmer
- Lungesygdomme
- Neoplasmer efter sted
- Neoplasmer i luftvejene
- Thoracale neoplasmer
- Karcinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karcinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Nukleinsyresyntesehæmmere
- Enzymhæmmere
- Antineoplastiske midler
- Folinsyreantagonister
- Pemetrexed
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 12092
- I2I-MC-JMMD (Anden identifikator: Eli Lilly and Company)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
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